Automated insertion assembly

ABSTRACT

An automated insertion assembly includes a first dermal perforation assembly configured to releasably engage a first subdermal device. A first actuation assembly is configured to drive the first dermal perforation assembly into a user&#39;s skin to a first depth and drive the first subdermal device into the user&#39;s skin to a second depth. The second depth is greater than the first depth.

CROSS REFERENCE TO RELATED APPLICATIONS

The application is a continuation of U.S. patent application Ser. No.12/029,234 filed on Feb. 11, 2008, which is claims priority to U.S.Provisional Ser. No.: 60/889,007 filed on Feb. 9, 2007, and entitled:TWO-STAGE TRANSCUTANEOUS INSERTER, each of which is hereby incorporatedby reference in its entirety.

TECHNICAL FIELD

This disclosure relates to insertion assemblies and, more particularly,to automated insertion assemblies.

BACKGROUND

Numerous devices (e.g., drug delivery systems, analyte monitoringsystems, including but not limited to blood glucose monitoring systemsor any system monitoring any patient condition from any patient fluid orphysiological characteristic) require that the skin of the user beingtested be perforated to allow for e.g., the supplying of drug to theuser and/or the monitoring of various bodily/physiological conditions(e.g., blood conditions, i.e., glucose levels or other analyte levelswhether in the blood or other fluid or indicative by another physicalcondition, i.e., temperature). The difficulty with these devices iscompounded where two or more are used.

Unfortunately, such systems may require the user to manually insert thevarious cannulas and/or probes into or onto their skin, often resultingin incorrect insertions and discomfort/pain. This problem is compoundedwhen the user is using multiple devices e.g., an insulin delivery systemand a blood glucose monitoring system.

SUMMARY OF DISCLOSURE

In a first implementation, an automated insertion assembly includes afirst dermal perforation assembly configured to releasably engage afirst subdermal device. A first actuation assembly is configured todrive the first dermal perforation assembly into a user's skin to afirst depth and drive the first subdermal device into the user's skin toa second depth. The second depth is greater than the first depth.

One or more of the following features may be included. The firstsubdermal device may be chosen from the group consisting of a cannulaassembly and a probe. The first dermal perforation assembly may includea first insertion needle assembly for at least partially encapsulatingat least a portion of the first subdermal device. The first actuationassembly may include a first actuator for providing mechanical energysufficient to drive the first dermal perforation assembly into theuser's skin to the first depth and drive the first subdermal device intothe user's skin to the second depth. The first actuator may be aspring-based actuator.

The first actuation assembly may include one or more gear assemblies forat least partially coupling the first actuator to the first dermalperforation assembly. The first actuation assembly may include one ormore linkage assemblies for at least partially coupling the firstactuator to the first dermal perforation assembly.

A second dermal perforation assembly may be configured to releasablyengage a second subdermal device. A second actuation assembly may beconfigured to drive the second dermal perforation assembly into theuser's skin to a third depth and drive the second subdermal device intothe user's skin to a fourth depth. The fourth depth may be greater thanthe third depth. The fourth depth may be less than/equal to the thirddepth.

The second subdermal device may be chosen from the group consisting of acannula assembly and a probe. The second dermal perforation assembly mayinclude a second insertion needle assembly for at least partiallyencapsulating at least a portion of the second subdermal device. Thesecond actuation assembly may include a second actuator for providingmechanical energy sufficient to drive the second dermal perforationassembly into the user's skin to the third depth and drive the secondsubdermal device into the user's skin to the fourth depth.

The second actuator may be a spring-based actuator. The second actuationassembly may include one or more gear assemblies for at least partiallycoupling the second actuator to the second dermal perforation assembly.The second actuation assembly may include one or more linkage assembliesfor at least partially coupling the second actuator to the second dermalperforation assembly. The first actuation assembly and the secondactuation assembly may be a single actuation assembly.

In another implementation, an automated insertion assembly includes afirst dermal perforation assembly configured to releasably engage afirst subdermal device. A second dermal perforation assembly isconfigured to releasably engage a second subdermal device. An actuationassembly is configured to: drive the first dermal perforation assemblyinto a user's skin to a first depth, drive the first subdermal deviceinto the user's skin to a second depth, drive the second dermalperforation assembly into the user's skin to a third depth, and drivethe second subdermal device into the user's skin to a fourth depth. Thesecond depth is greater than the first depth.

One or more of the following features may be included. The fourth depthmay be greater than the third depth. The fourth depth may be lessthan/equal to the third depth. The first subdermal device and the secondsubdermal device may be chosen from the group consisting of a canularassembly and a probe.

The first dermal perforation assembly may include a first insertionneedle assembly for at least partially encapsulating at least a portionof the first subdermal device. The second dermal perforation assemblymay include a second insertion needle assembly for at least partiallyencapsulating at least a portion of the second subdermal device. Theactuation assembly may include an actuator for providing mechanicalenergy sufficient to drive the first dermal perforation assembly into auser's skin to a first depth, drive the first subdermal device into theuser's skin to a second depth, drive the second dermal perforationassembly into the user's skin to a third depth, and drive the secondsubdermal device into the user's skin to a fourth depth. The actuatormay be a spring-based actuator.

In another implementation, an automated insertion assembly includes afirst dermal perforation assembly configured to releasably engage afirst subdermal device, a second subdermal device, and an actuationassembly. The actuation assembly is configured to: drive the firstdermal perforation assembly into a user's skin to a first depth, drivethe first subdermal device into the user's skin to a second depth, anddrive the second subdermal device into the user's skin to a third depth.The second depth is greater than the first depth.

One or more of the following features may be included. The secondsubdermal device may be a cannula assembly. The first dermal perforationassembly may include a first insertion needle assembly for at leastpartially encapsulating at least a portion of the first subdermaldevice. The actuation assembly may include an actuator for providingmechanical energy sufficient to drive the first dermal perforationassembly into a user's skin to a first depth, drive the first subdermaldevice into the user's skin to a second depth, and drive the secondsubdermal device into the user's skin to a third depth.

The details of one or more implementations are set forth in theaccompanying drawings and the description below. Other features andadvantages will become apparent from the description, the drawings, andthe claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic view of an automated insertion assembly;

FIG. 2 is another diagrammatic view of the automated insertion assemblyof FIG. 1;

FIG. 3 is a diagrammatic view of an insertion needle assembly of theautomated insertion assembly of FIG. 1;

FIG. 4 is another diagrammatic view of the automated insertion assemblyof FIG. 1;

FIG. 5 is another diagrammatic view of the automated insertion assemblyof FIG. 1;

FIG. 6 is another diagrammatic view of the automated insertion assemblyof FIG. 1;

FIG. 7 is another diagrammatic view of the automated insertion assemblyof FIG. 1;

FIG. 8 is another diagrammatic view of the automated insertion assemblyof FIG. 1;

FIG. 9A is a diagrammatic view of a crank assembly of the automatedinsertion assembly of FIG. 1;

FIG. 9B is a diagrammatic view of an alternative embodiment of the crankassembly of FIG. 9A;

FIG. 9C is a diagrammatic view of an alternative embodiment of the crankassembly of FIG. 9A;

FIG. 10 is a diagrammatic view of a spring-based actuator of theautomated insertion assembly of FIG. 1;

FIGS. 11A-11B are front and back views of a sharps cartridge ofautomated insertion assembly of FIG. 1;

FIG. 12 is an isometric view of a cartridge assembly for housing thesharps cartridge of FIGS. 11A-11B;

FIGS. 13A-13B are various isometric views of the automated insertionassembly of FIG. 1;

FIG. 14A is a series of views of a dermal perforation assembly of theautomated insertion assembly of FIG. 1;

FIG. 14B is an isometric view of the dermal perforation assembly of FIG.14A;

FIGS. 15A-15L are a series of views of an alternative embodiment of theautomated insertion assembly of FIG. 1; and

FIGS. 16-18 are isometric views of a gear assembly/actuator of theautomated insertion assembly of FIG. 1.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The following description describes various embodiments of an automatedinsertion assembly. The device is a mechanical device capable ofautomatically inserting or introducing one or more probes or sensors. Inone embodiment, the device includes automatically inserting at least oneprobe into a patient's skin by first inserting an introduction needlethat at least partially encapsulates the probe. The insertion needlereaches a predetermined first depth in the skin and is withdrawn by thedevice, leaving the probe behind. The device additionally includes apusher device that automatically and mechanically pushes the probes to asecond depth, deeper than the first depth. The pusher device is thenmechanically and automatically retracted.

In another embodiment, in addition to the probe insertion capabilitiesdescribed above, the inerter apparatus additionally includes a cannulaor other drug delivery insertion device. The cannula insertion deviceincludes an automatic and mechanical inserter that inserts a cannulausing an introduction needle. The insertion needle is automatically andmechanically retracted.

In one embodiment of the apparatus, both the cannula and probe areinserted simultaneously. The probe inserter includes a pusher where thecannula inserter does not. However, the introduction needles perforatethe skin simultaneously.

Inserting two devices at the same time has many advantages, includingbut not limited to, convenience and less pain and/or less number ofpainful events for the patient. Additionally, because both devices areinserted using the same apparatus, the spacing between the two devicesin the patient can be predetermined and thus, may increase accuracy,efficiency and safety in the use of the devices. For example, in someapplications, the inserter is used to insert two or more probes or otherdevices; at appropriate distances one from another. However, in otherapplications where a probe and delivery device are inserted together,the probes or probe and delivery device should be spaced apart a minimumdistance for accuracy. Inserting both devices using the same inserterassures the patient inserts both devices at the minimum recommendeddistance. Additionally, in some embodiments, the inserter may apply twoor more sensors or probes at a predetermined distance, where thereadings between the sensors or probes are indicative. In theseembodiments, the distance between the probes or sensors is maintainedfor accuracy and/or to eliminate or minimize interference. Thus, again,in this instance, the inserter assures the correct distance.

In another embodiment, the inserter inserts two or more probes, two ormore sensors or two or more cannulas or drug delivery devicessimultaneously. In still further embodiments, the inserter may insert avariety of sensors or probes or all the same sensors or probes and/ordrug delivery paths, cannulas or needles.

Referring to FIGS. 1, 2, 3, 3L, 3R & 3T, there is shown automatedinsertion assembly 10 that may include first dermal perforation assembly12 that may be configured to releasably engage first subdermal device14. First actuation assembly 16 may be configured to drive first dermalperforation assembly 12 into a user's skin 18 to a first depth and drivefirst subdermal device 14 into user's skin 18 to a second depth. Themanner in which automated insertion assembly 10 drives first dermalperforation assembly 12 to a first depth and drives first subdermaldevice 14 to a second depth is described below in greater detail.Typically, the second depth (i.e. the depth to which first subdermaldevice 14 is driven) is greater than the first depth (i.e. the depth towhich first dermal perforation assembly 12 is driven), thus allowingfirst subdermal device 14 to penetrate skin that was not previouslypenetrated/damaged by first dermal perforation assembly 12. However, thesecond depth in some embodiments may be equal or less than the firstdepth.

Examples of first subdermal device 14 may include but are not limited toa cannula assembly, a needle assembly, an infusion assembly, a glucosemonitoring probe, a potassium or any electrolyte and/or analytemonitoring probe, or any type of probe that monitors any chemical,analyte or physiological characteristic including, but not limited to,hydration and/or temperature and/or conductivity/electrical pulses. Instill other embodiments, the probes may impart an electricalstimulation. Additionally, in some embodiments, the device may includean RF transmitter or compounds. In one embodiment, the compound is anytherapeutic compound, and dissolves into the dermal layer over a periodof time. In still other embodiments, the device may include, but is notlimited to, a bedside IV or other patient monitoring assembly, or anyother device used to monitor physiological conditions.

Automated insertion assembly 10 may be included within (or a portion of)various other devices (e.g., device 22), examples of which may includebut are not limited to an infusion pump assembly, a glucose monitoringsystem, a potassium or any electrolyte monitoring system, an analytemonitoring system or any type of system or device that monitors anychemical or physiological characteristic including, but not limited to,hydration and/or temperature and/or conductivity. In still otherembodiments, the probes may impart an electrical stimulation and may bepart of an electrical stimulation device. Additionally, in someembodiments, the device may include an RF transmitter or compounds. Inone embodiment, the compound is any therapeutic compound system, and inone embodiment, the system provides for a compound that dissolves intothe dermal layer over a period of time. In still other embodiments, thedevice may include, but is not limited to, a bedside IV or other patientmonitoring assembly, or any other device used to monitor physiologicalconditions. Further, automated insertion assembly 10 may be separatefrom (but tethered to) various other devices (e.g. device 24), examplesof which may include but are not limited to an infusion pump assembly, aglucose monitoring system or probe, a potassium or any electrolytemonitoring system or probe, or any type of probe or system that monitorsany chemical, analyte or physiological characteristic including, but notlimited to, hydration and/or temperature. Additionally, in someembodiments, the device may include an RF transmitter or compounds. Inone embodiment, the compound is any therapeutic compound, and dissolvesinto the dermal layer over a period of time. In still other embodiments,the device may include, but is not limited to, a bedside IV or otherpatient monitoring assembly, or any other device used to monitorphysiological conditions.

First dermal perforation assembly 12 may include first insertion needleassembly 28 that may be configured to at least partially encapsulate atleast a portion of first subdermal device 14. However, in someembodiments, an insertion needle assembly is not included.

First actuation assembly 16 may include first actuator 30 for providingmechanical energy sufficient to drive first dermal perforation assembly12 into user's skin 18 to the first depth and drive first subdermaldevice 14 into user's skin 18 to the second depth. Examples of firstactuator 30 may include but are not limited to a spring-based actuator(not shown), a motor-based actuator (not shown), a pneumatic-basedactuator (not shown), and a shape memory wire-based actuator (notshown).

First actuation assembly 16 may include one or more gear assemblies (tobe discussed below in greater detail) for at least partially couplingfirst actuator 30 to first dermal perforation assembly 12.Additionally/alternatively, first actuation assembly 16 may include oneor more linkage assemblies (to be discussed below in greater detail) forat least partially coupling first actuator 30 to first dermalperforation assembly 12.

First insertion needle assembly 28 of first dermal perforation assembly12 may be configured to allow first subdermal device 14 to exit fromfirst insertion needle assembly 28. For example, first insertion needleassembly 28 may include longitudinal slot 32 through which firstsubdermal device 14 may exit from first insertion needle assembly 28.Specifically, first insertion needle assembly 28 may be a traditionalhypodermic-type (i.e. hollow core) needle assembly. As shown in FIG. 3T(which is a cross-sectional view of FIG. 3 along section line AA), firstinsertion needle assembly 28 may include interior passage 34 which maybe sized to receive first subdermal device 14. As shown in FIG. 3R (i.e.a right-side view of first insertion needle assembly 28 in the directionof arrow 36) and FIG. 3L (i.e. a left-side view of first insertionneedle assembly 28 in the direction of arrow 38), longitudinal slot 32may extend the entire length of first insertion needle assembly 28.Alternatively, longitudinal slot 32 may extend a partial length of firstinsertion needle assembly 28, wherein the partial length is positionedto allow first subdermal device 14 to exit first insertion needleassembly 28 at the appropriate position along the length of firstinsertion needle assembly 28.

Referring to FIG. 4, automated insertion assembly 10 may include seconddermal perforation assembly 50. Second dermal perforation assembly 50may be configured to releasably engage second subdermal device 52. Asecond actuation assembly (not shown) may be configured to drive seconddermal perforation assembly 50 into user's skin 18 to a third depth anddrive second subdermal device 52 into user's skin 18 to a fourth depth.This second actuation assembly (not shown) may include a second actuatorfor providing the mechanical energy sufficient to drive second dermalperforation assembly 50 into user's skin 18 to the third depth and drivesecond subdermal device 52 into user's skin 18 to the fourth depth.Examples of this second actuator (not shown) may include but are notlimited to a spring-based actuator (not shown), a motor-based actuator(not shown), a pneumatic-based actuator (not shown), and a shape memorywire-based actuator (not shown).

In alternate embodiments of automated insertion assembly 10, the variousdermal perforation assemblies may be configured such that one or moreare driven to equal depths. In one embodiment, all of the assemblies aredriven to equal depths.

In a fashion similar to that of first actuation assembly 16, the secondactuation assembly (not shown) may include one or more gear assemblies(to be discussed below in greater detail) for at least partiallycoupling the second actuator (not shown) to second dermal perforationassembly 50. Additionally/alternatively, the second actuation assembly(not shown) may include one or more linkage assemblies (to be discussedbelow in greater detail) for at least partially coupling the secondactuator (not shown) to second dermal perforation assembly 50.

Alternatively, first dermal perforation assembly 12 and second dermalperforation assembly 50 may be driven by a common actuation assembly(e.g. first actuation assembly 16) and/or a common actuator (e.g. firstactuator 30).

Typically, the fourth depth (i.e. the depth to which second subdermaldevice 52 is driven) is greater than the third depth (i.e. the depth towhich second dermal perforation assembly 50 is driven), thus allowing asecond subdermal device 52 to penetrate skin that was not previouslypenetrated/damaged by second dermal perforation assembly 50.

The third depth (i.e. the depth to which second dermal perforationassembly 50 is driven) may be the same as or different from the firstdepth (i.e. the depth to which first dermal perforation assembly 12 isdriven). Further, the fourth depth (i.e. the depth to which secondsubdermal device 52 is driven) may be the same as or different from thefirst depth (i.e. the depth to which first subdermal device 14 isdriven).

In a fashion similar to that of first subdermal device 14, examples ofsecond subdermal device 52 may include but are not limited to a cannulaassembly, a glucose monitoring probe, a potassium or any electrolytemonitoring probe, or any type of probe that monitors any chemical,analyte or physiological characteristic including, but not limited to,hydration and/or temperature. Additionally, in some embodiments, thedevice may include an RF transmitter or compounds. In one embodiment,the compound is any therapeutic compound, and dissolves into the dermallayer over a period of time. In still other embodiments, the device mayinclude, but is not limited to, a bedside IV or other patient monitoringassembly, or any other device used to monitor physiological conditions.

In a fashion similar to that of first dermal perforation assembly 12,second dermal perforation assembly 50 may include second insertionneedle assembly 54 that may be configured to at least partiallyencapsulate at least a portion of second subdermal device 52. Secondinsertion needle assembly 54 of second dermal perforation assembly 50may be configured to allow second subdermal device 52 to exit secondinsertion needle assembly 54. For example, second insertion needleassembly 54 may include a longitudinal slot (similar to that of firstinsertion needle assembly 28) through which second subdermal device 52may exit second insertion needle assembly 54.

As discussed above, in one embodiment, first dermal perforation assembly12 may be driven into user's skin 18 to a first depth; first subdermaldevice 14 may be driven into user's skin 18 to a second depth; seconddermal perforation assembly 50 may be driven into user's skin 18 to athird depth; and second subdermal device 52 may be driven into user'sskin 18 to a fourth depth. However, in other embodiments, first dermalperforation assembly 12 and/or any one or more of the subdermal devices14, 52 may be ultimately driven to the same depths. Thus, herein, theterms first depth, second depth, etc., may mean different depths or thesame depth, depending on the embodiment. However, it should beappreciated that automated insertion assembly 10 allows one or moredevices to be inserted at the same or different depth.

Thus, automated insertion assembly 10 may be configured to drive firstdermal perforation assembly 12 to a first depth; drive first subdermaldevice 20 to a second depth; drive second dermal perforation assembly 50to a third depth; and drive second subdermal device 52 to a fourthdepth, in a variety of different ways, each of which is considered to bewithin the scope of this disclosure.

Accordingly and for illustrative purposes only, a first configuration isillustrated in FIGS. 4-8. As shown in FIG. 4, first actuation assembly16 (and/or a second actuation assembly, not shown) may displace linkageassembly 100 and/or linkage assembly 102 in the direction of arrows 104,106 (respectively). Linkage assemblies 100, 102 may be coupled to one ormore gear assemblies coupled to e.g., first actuator 30. For example, ifactuator 30 is a motor, an output shaft (not shown) of actuator 30 mayinclude a gear assembly (not shown) to e.g., mesh with a rack gearassembly (not shown) included within e.g., linkage assembly 100, thusallowing for the conversion of rotational energy into lineardisplacement.

The displacement of linkage assembly 100 and/or linkage assembly 102 mayresult in first dermal perforation assembly 12 (and first insertionneedle assembly 28) and/or second dermal perforation assembly 50 (andsecond insertion needle assembly 54) moving toward user's skin 18.Automated insertion assembly 10 may include one or more depth stops(e.g., depth stops 108, 110) for controlling the total displacementexperienced by first dermal perforation assembly 12 and/or second dermalperforation assembly 50.

The positioning of depth stops 108, 110 is for illustrative purposesonly and is not intended to be a limitation of this disclosure. Forexample, depth stops 108, 110 may be positioned lower or higher withinautomated insertion assembly 10, or first dermal perforation assembly 12and/or second dermal perforation assembly 50 may be configured to“bottom out” on the surface of user's skin 18.

Referring also to FIG. 5, first dermal perforation assembly 12 and/orsecond dermal perforation assembly 50 may continue to move downwarduntil (in this particular example) first dermal perforation assembly 12contacts depth stop 108 and/or second dermal perforation assembly 50contacts depth stop 110. Once depth stop 108 and/or depth stop 110contacts first dermal perforation assembly 12 and/or second dermalperforation assembly 50, one or more spring assemblies (e.g. springassembly 112 and/or spring assembly 114) may begin to compress.Specifically, spring assembly 112 and/or spring assembly 114 may besized to provide a mechanical resistance that is sufficient to drivefirst insertion needle assembly 28 (included within first dermalperforation assembly 12) and/or second insertion needle assembly 54(included within second dermal perforation assembly 50) into user's skin18.

The positioning of spring assemblies 112, 114 is for illustrativepurposes only and is not intended to be a limitation of this disclosure.For example, spring assemblies 112, 114 may be positioned lower withinautomated insertion assembly 10 to reduce the overall height ofautomated insertion assembly 10.

Referring also to FIG. 6, spring assembly 112 and/or spring assembly 114may continue to compress. Further, in this particular example, linkageassembly 100 is shown to be directly coupled to a portion (e.g., portion116) of first subdermal device 14. Depth stop 108 may be positioned toallow linkage assembly 100 to drive first dermal perforation assembly 12to the above-described first depth.

Accordingly, once depth stop 108 is encountered by first dermalperforation assembly 12, all downward movement of first dermalperforation assembly 12 may cease. However, as spring assembly 112compresses, linkage assembly 100 may continue to move in a downwarddirection. Further, as first subdermal device 14 is (in this particularexample) directly coupled to linkage assembly 100 (via portion 116),first subdermal device 14 may continue to move in a downward direction,continuing to penetrate user's skin 18 to a depth (e.g., theabove-described second depth) that is deeper than the depth of firstinsertion needle assembly 28 of first dermal perforation assembly 12(e.g., the above-described first depth).

Portion 116 of first subdermal device 14 may e.g. contain electroniccircuitry and/or sensing devices that process the data obtained by firstsubdermal device 14. Alternatively, portion 116 of first subdermaldevice 14 may simply be a rigid device upon which linkage assembly 100may provide downward pressure to drive first subdermal device 14 to theabove-described second depth.

At least a portion of first subdermal device 14 (e.g. the portionpenetrating user's skin 18) may be constructed of a material that issufficiently rigid to penetrate user's skin 18. Examples of such amaterial may include but are not limited to steel, stainless steel,titanium, or plastic. Accordingly, when linkage assembly 100 continuesto provide downward force (in the direction of arrow 104), firstsubdermal device 14 may continue to penetrate user's skin 18 until thedesired depth (e.g., the above-described second depth) is achieved.While the above-described first depth (i.e., the depth of firstinsertion needle 28 of first dermal perforation assembly 12) may beadjusted by adjusting (in this example) the position of depth stop 108),the above-described second depth (i.e., the depth of first subdermaldevice 14) may be adjusted by adjusting the total travel of linkageassembly 100.

Additionally and in this particular example, linkage assembly 102 isshown to be directly coupled to a portion (e.g., portion 118) of secondsubdermal device 52. Depth stop 110 may be positioned to allow linkageassembly 102 to drive second dermal perforation assembly 50 to theabove-described third depth.

Accordingly, once depth stop 110 is encountered by second dermalperforation assembly 50, all downward movement of second dermalperforation assembly 50 may cease. However, as spring assembly 114compresses, linkage assembly 102 may continue to move in a downwarddirection. Further, as second subdermal device 52 is (in this particularexample) directly coupled to linkage assembly 102 (via portion 118),second subdermal device 52 may continue to move in a downward direction,continuing to penetrate user's skin 18 to a depth (e.g., theabove-described fourth depth) that is deeper than the depth of secondinsertion needle assembly 54 of second dermal perforation assembly 50(e.g., the above-described third depth).

Portion 118 of second subdermal device 52 may e.g. contain electroniccircuitry and/or sensing devices that process the data obtained bysecond subdermal device 52. Alternatively, portion 118 of secondsubdermal device 52 may simply be a rigid device upon which linkageassembly 102 may provide downward pressure to drive second subdermaldevice 52 to the above-described fourth depth.

At least a portion of second subdermal device 52 (e.g. the portionpenetrating user's skin 18) may be constructed of a material that issufficiently rigid to penetrate user's skin 18. Examples of such amaterial may include but are not limited to steel, stainless steel,titanium, or plastic. Accordingly, when linkage assembly 102 continuesto provide downward force (in the direction of arrow 106), secondsubdermal device 52 may continue to penetrate user's skin 18 until thedesired depth (e.g., the above-described fourth depth) is achieved.While the above-described third depth (i.e., the depth of secondinsertion needle 54 of second dermal perforation assembly 50) may beadjusted by adjusting (in this example) the position of depth stop 110),the above-described fourth depth (i.e., the depth of second subdermaldevice 52) may be adjusted by adjusting the total travel of linkageassembly 102.

Continuing with the above-stated example and referring also to FIG. 7,upon achieving the desired depth (i.e. the above-described second depthfor first subdermal device 14 and/or the above-described fourth depthfor second subdermal device 52), linkage assembly 100 and/or linkageassembly 102 may begin to move upward in the direction of arrow 200and/or arrow 202. Accordingly, spring assembly 112 and/or springassembly 114 may decompress. As linkage assembly 100 and/or linkageassembly 102 move in an upward direction, linkage assembly 100 and/orlinkage assembly 102 may move away from portion 116 of first subdermaldevice 14 and/or portion 118 of second subdermal device 52. Accordingly,while linkage assembly 100 and/or linkage assembly 102 move upward,first subdermal device 14 and or second subdermal device 52 may remainwithin user skin 18.

Referring also to FIG. 8, once spring assembly 112 and/or springassembly 114 are fully decompressed, first dermal perforation assembly12 and/or second dermal perforation assembly 50 may begin to move upward(i.e. away from depth stops 108, 110 respectively). Accordingly, firstinsertion needle assembly 28 of first dermal perforation assembly 12 mayalso move upward and may be removed from user's skin 18. Further, secondinsertion needle assembly 54 of second dermal perforation assembly 50may also move upward and may be removed from user's skin 18.

As discussed above, automated insertion assembly 10 may be configured todrive first dermal perforation assembly 12 to a first depth; drive firstsubdermal device 14 to a second depth; drive second dermal perforationassembly 50 to a third depth; and drive second subdermal device 52 to afourth depth, in a variety of different ways, each of which isconsidered to be within the scope of this disclosure. Accordingly, whileFIGS. 4-8 illustrates a single linkage assembly (e.g. linkage assembly100), wherein each linkage assembly utilizes a spring assembly (e.g.spring assembly 112) to allow e.g. first subdermal device 14 to beinserted into user's skin 18 at a depth greater than that of firstinsertion needle assembly 28 of first dermal perforation assembly 12,other configurations are possible and are considered to be within thescope of this disclosure.

For example and referring also to FIG. 9A, an actuator (e.g. actuator30) included within an actuation assembly (e.g. actuation assembly 16)may be configured to rotate crank assembly 300, which rotates aboutcenterline 302. Crank assembly 300 may be configured as a variablestroke crank assembly. For example, first rod journal 304 may be offset(with respect to main journal 306) by a distance of 50% of the seconddepth and second rod journal 308 may be offset (with respect to mainjournal 306) by a distance of 50% of the first depth. Linkage assembly310 (e.g., a connecting rod) may be coupled to rod journal 304 andconfigured to drive first subdermal device 14 and linkage assembly 312(e.g., a connecting rod) may be coupled to rod journal 308 andconfigured to drive first dermal perforation assembly 12. Accordingly,as crank assembly 300 rotates about centerline 302, linkage assembly 310is linearly displaced the distance required to achieve theabove-described second depth and linkage assembly 312 is linearlydisplaced the distance required to achieve the above-described firstdepth.

Referring also to FIG. 9B, an alternative crank assembly 300′ is shown.As with crank assembly 300, crank assembly 300′ may be configured as avariable stroke crank assembly. Accordingly, as crank assembly 300′rotates, linkage assembly 310 is linearly displaced the distancerequired to achieve the above-described second depth and linkageassembly 312 is linearly displaced the distance required to achieve theabove-described first depth.

Referring also to FIG. 9C, an alternative crank assembly 300″ is shownthat utilizes a single linkage assembly (e.g., linkage assembly 310′).Other alternative embodiments may utilize a plurality of crankassemblies (not shown).

As discussed above, first actuator 30 (and/or the second actuator, notshown) may be a spring-based actuator. Referring also to FIG. 10A-10D,an example of such a spring-based actuator is shown. Spring-basedactuator 400 may be configured to drive first dermal perforationassembly 12 and/or second dermal perforation assembly 50 (and firstinsertion needle assembly 28 and/or second insertion needle assembly 54,respectively) downward (as shown in FIGS. 10B-10C) and subsequentlyupward (as shown in FIGS. 10D-10E).

Referring also to FIGS. 11A (front view) and 11B (back view), there isshown first dermal perforation assembly 12′ (i.e., an alternativeembodiment of first dermal perforation assembly 12) and second dermalperforation assembly 50′ (i.e., an alternative embodiment of seconddermal perforation assembly 50). Together, the combination of firstdermal perforation assembly 12′ and second dermal perforation assembly50′ may be referred to as a “sharps cartridge” 450.

As with the above-described system, first dermal perforation assembly12′ may include first insertion needle assembly 28′ and second dermalperforation assembly 50′ may include second insertion needle assembly54′. For illustrative purposes and in this particular embodiment, firstdermal perforation assembly 12′ is shown to be configured to effectuatethe insertion of a glucose monitoring probe (i.e., first subdermaldevice 14′) and second dermal perforation assembly 50′ is shown to beconfigured to effectuate the insertion of a cannula assembly (i.e.,second subdermal device 52′). Depending on the manner in which thecannula assembly (i.e., second subdermal device 52′) is configured, thecannula assembly may or may not include a septum assembly (i.e., aself-sealing and piercable member for establishing fluid communicationwith a medical device, such as a fluid delivery device).

In this particular embodiment, the cannula assembly (i.e., secondsubdermal device 52′) may be constructed of a semi-rigid/rigid materialand therefore may be capable of penetrating user's skin 18 (FIG. 2)without the use of second insertion needle assembly 54′ of second dermalperforation assembly 50′. Accordingly and when configured in such amanner, second insertion needle assembly 54′ may not be required and,therefore, may not be included within second dermal perforation assembly50′.

Alternatively, the cannula assembly (i.e., second subdermal device 52′)may be constructed of a non-rigid material and, therefore, may beincapable of penetrating user's skin 18 (FIG. 2) without the use ofsecond insertion needle assembly 54′. Accordingly and when configured insuch a manner, second insertion needle assembly 54′ may be required and,therefore, may be included within second dermal perforation assembly50′.

Further and in this particular embodiment, the glucose monitoring probe(i.e., first subdermal device 14′) may be constructed of a non-rigidmaterial and, therefore, may be incapable of penetrating user's skin 18(FIG. 2) without the use of first insertion needle assembly 28′ and,therefore, may be included within first dermal perforation assembly 12′.

As discussed above, one or more spring assemblies (e.g., springassemblies 112, 114) may be included within automated insertion assembly10 to allow for the insertion of one or more of the subdermal devices toa depth (i.e., within user's skin 18) that is deeper than that of thecorresponding insertion needle assembly. Accordingly and in thisparticular embodiment, first dermal perforation assembly 12′ is shown toinclude an alternative embodiment spring assembly (i.e., spring assembly112′). In this particular example, spring assembly 112′ may be a portionof and molded within first dermal perforation assembly 12′. Springassembly 112′ may be sized to provide a mechanical resistance that issufficient to drive first insertion needle assembly 28′ (included withinfirst dermal perforation assembly 12′) into user's skin 18.

Once all downward movement of first dermal perforation assembly 12′ceases (due to e.g., encountering a depth stop, as described above),spring assembly 112′ may compress and the above-described linkageassembly (e.g., linkage assembly 100) may continue to drive firstsubdermal device 14′ in a downward direction and further into user'sskin 18 to a depth (e.g., the above-described second depth) that isdeeper than the depth of first insertion needle assembly 28′ of firstdermal perforation assembly 12′ (e.g., the above-described first depth).

In this particular embodiment, sharps cartridge 450 is shown to includeslots 452, 454 within which tabs 456, 458 may be positioned. Tabs 456,458 maybe coupled to the above-described linkage assembly (e.g., linkageassembly 100).

Referring also to FIG. 12, there is shown cartridge assembly 500 forcarrying sharps cartridge 450, thus protecting the user of sharpscartridge 450 from being accidentally punctured by the glucosemonitoring probe (i.e., first subdermal device 14′) and/or the cannulaassembly (i.e., second subdermal device 52′).

Referring also to FIGS. 13A-13C, there is shown an illustrative andexemplary process for loading cartridge assembly 500 into automatedinsertion assembly 10. For example and in this embodiment, when loadingcartridge assembly 500 into automated insertion assembly 10, the usermay pivot cover assembly 502 of automated insertion assembly 10 toexpose slot 504 into which cartridge assembly 500 may be placed (asshown in FIG. 13A). Cartridge assembly 500 may include a toothed track506 for releasably engaging one of the above-described gear assemblies.

Once cover assembly 502 is pivoted, the user may align cartridge 500with slot 504 in automated insertion assembly 10 (as shown in FIG. 13B)and insert cartridge 500 into automated insertion assembly 10.

In this particular embodiment, insertion of cartridge assembly 500 intoslot 504 of automated insertion assembly 10 may result in the “cocking”of the automated insertion assembly 10 to prepare automated insertionassembly 10 to deliver cartridge assembly 500. For example and asdiscussed above, automated insertion assembly 10 may include firstactuation assembly 16 (FIG. 2), which may include first actuator 30(FIG. 2). As discussed above, examples of first actuator 30 may includebut are not limited to a spring-based actuator (not shown), amotor-based actuator (not shown), a pneumatic-based actuator (notshown), and a shape memory wire-based actuator (not shown). Assumingthat first actuator 30 is a spring-based actuator, upon the userinserting cartridge assembly 500 into slot 504 of automated insertionassembly 10, first actuator 30 (i.e., a spring-based actuator in thisexample) may be wound. Alternatively, other “cocking” procedures may beemployed, which may include but are not limited to a “cocking” lever(not shown) that winds the above-described spring-based actuator (e.g.,first actuator 30).

Once cartridge assembly 500 is fully inserted into slot 504, the usermay reverse pivot cover assembly 502 (as shown in FIG. 13C).

As discussed above, when inserting e.g., first subdermal device 14′ intouser's skin 18, first subdermal device 14′ may be inserted to a depththat is greater than the depth to which first insertion needle assembly28′ (included within first dermal perforation assembly 12′) is insertedinto user's skin 18.

For example and referring also to FIGS. 14A-14B, first dermalperforation assembly 12′ may be driven toward user's skin 18. Uponcontact with user's skin 18, first insertion needle assembly 28′(included within first dermal perforation assembly 12′) may be insertedinto user's skin 18. Additionally, first dermal perforation assembly 12′(e.g., a glucose monitoring probe in this example) may also be insertedinto user's skin 18. Additional downward force may be applied to firstdermal perforation assembly 12′ and, for the reasons discussed above,first dermal perforation assembly 12′ (e.g., a glucose monitoring probein this example) may continue to be driven downward (i.e., into user'sskin 18).

In this particular embodiment, base 550 of automated insertion assembly10 may include a recess configured to receive first subdermal device14′, thus allowing first subdermal device 14′ to be driven furtherdownward into user's skin 18 to a level that is deeper than that offirst insertion needle assembly 28′. Once first subdermal device 14′ ispositioned at the appropriate depth, first dermal perforation assembly12′ may move upwardly to extract first insertion needle assembly 28′from user's skin 18, resulting in first subdermal device 14′disconnecting from first dermal perforation assembly 12′, thus allowingfirst dermal perforation assembly 12′ to remain within user's skin 18.

Referring also to FIG. 15A-15L, there is shown a series of illustrationsof another embodiment of automated insertion assembly 10 (i.e.,automated insertion assembly 10′). In this particular embodiment,automated insertion assembly 10′ may includes actuator platform 600 thatis slidably seated upon one or more carriage guides (e.g., carriageguide 602) that may be driven by e.g., first actuator 30 included withinactuation assembly 16. As discussed above, examples of first actuator 30may include but are not limited to a spring-based actuator (not shown),a motor-based actuator (not shown), a pneumatic-based actuator (notshown), and a shape memory wire-based actuator (not shown).

First dermal perforation assembly 12′, second dermal perforationassembly 50′ and/or cartridge assembly 500 (which was described above asincluding first dermal perforation assembly 12′, and second dermalperforation assembly 50′) may be releasably attached to (e.g., clippedto) actuator platform 600 via one or more clip regions/assemblies (notshown). One or more tabs (e.g., tabs 456, 458) may protrude throughslots 452, 454 (FIG. 11) within e.g., first dermal perforation assembly12′, second dermal perforation assembly 50′ and/or cartridge assembly500. As actuator platform 600 travels toward user's skin 18 (FIG. 2),the various insertion needle assemblies may penetrate user's skin 18.When (for the reasons discussed above), first dermal perforationassembly 12′, second dermal perforation assembly 50′ and/or cartridgeassembly 500 can no longer travel in a downward direction (i.e., towarduser's skin 18), first subdermal device 14′ and/or second subdermaldevice 52′ may continue to be driven downward (i.e., into user's skin18) until the desired depth is achieved (which e.g., may be greater thanthe depth of first insertion needle assembly 28′ and/or second insertionneedle assembly 54′). Once properly inserted, actuator platform 600 maybegin traveling upward, extracting first dermal perforation assembly12′, second dermal perforation assembly 50′ and/or cartridge assembly500.

As discussed above, automated insertion assembly 10 may include one ormore gear assemblies that may be configured to at least partially couplethe actuators (e.g., first actuator 30) included within automatedinsertion assembly 10 to the dermal perforation assemblies (e.g., firstdermal perforation assembly 12) included within automated insertionassembly 10.

Referring also to FIGS. 16-17, there is shown one embodiment of theabove-described gear assemblies coupled to one embodiment of an actuator(e.g., first actuator 30). In this particular embodiment, automatedinsertion assembly 10 is shown in the above-described “cocked” position,as cartridge assembly 500 is shown in a position that is indicative ofbeing inserted within automated insertion assembly 10. As discussedabove, when in the “cocked” position, the various insertion needleassemblies included within cartridge assembly 500 are ready to beinserted into user's skin 18. When inserting cartridge assembly 500 intoautomated insertion assembly 10, toothed track 506 within cartridgeassembly 500 may releasably engage the uppermost gear of drive gear set650, resulting in the uppermost gear rotating clockwise, raisingactuator 652, and winding torsion spring 654 (i.e., the actuator), thus“cocking” automated insertion assembly 10 with sufficient potentialenergy to insert the various insertion needle assemblies and subdermaldevices into user's skin 18.

Once “cocked”, torsion spring 654 may also have enough stored energy toremove the various insertion needle assemblies, while leaving thesubdermal devices within user's skin 18. After full insertion ofcartridge assembly 500 into automated insertion assembly 10, theuppermost gear within drive gear set 650 may be seated in a toothlessgroove and, therefore, may spin freely upon actuation without movingcartridge assembly 500.

Prior to closing cover assembly 502 (FIGS. 13A-130), actuator 652 may beplaced into a retracted position by rotating retraction gears 656. Theprocess of retracting actuator 652 may be accomplished via e.g., coverassembly 502. Accordingly, when closing cover assembly 502, retractiongears 656 may rotate in the opposite direction, inserting e.g., tabs456, 458 (FIGS. 11A-11B) into slots 452, 454 (FIGS. 11A-11B). Safetycatch 658 may be used to prevent the untimely “firing” of cartridgeassembly 500 into user's skin 18.

To activate this particular embodiment of automated insertion assembly10, the upper portion of release lever 660 may be pushed forward,causing release lever 660 to pivot about fulcrum 662 and disengagetrigger catch 664 from a cooperatively shaped recess in drive wheel 666.Torsion spring 654 may then cause drive gear set 650 to rotate, turningdrive wheel 666 and lowering actuator 652. As actuator 652 is lowered,teeth 668 within actuator 652 will slide through the longitudinalgrooves in retraction gear 656. The use of drive wheel 666 and theconnecting rod assemblies (e.g., connecting rod 670) may result in asinusoidal insertion velocity (with respect to the various insertionneedle assemblies included within sharps cartridge 500). Other insertionvelocity profiles may be created by e.g., replacing drive wheel 666 witha cam assembly (not shown).

Referring also to FIG. 18, there is shown the above-described gearassembly/actuator (i.e., of FIGS. 16-17) after “firing”, that is afterinsertion of insertion needle assemblies 28′. 54′ into user's skin 18.Typically, drive wheel 666 is configured so that after insertion ofinsertion needle assemblies 28′ 54′ (and the associated subdermaldevices), drive wheel 666 has sufficient momentum to continue to rotate,thus extracting insertion needle assemblies 28′ 54′ from user's skin 18.Depending upon the design of drive wheel 666 and the connecting rod(s),the kinetic profile of insertion and withdrawal may approximate asine-wave, i.e., starting slowly, accelerating and then slowing downagain.

If retraction gear shaft 672 is coupled to cover assembly 502, theopening of cover assembly 502 may actuate the retraction by disengagingtabs 456, 458 (FIGS. 11A-11B) from slots 452, 454 (FIGS. 11A-11B), thusallowing removal of cartridge assembly 500 from automated insertionassembly 10. Automated insertion assembly 10 may then be ready for reusewith a replacement sharps cartridge. One or more spring assemblies maycause cartridge assembly 500 to pop up out of slot 504 to simplifyremoval.

In one embodiment of automated insertion assembly 10, drive wheel 666may not rotate a full 360°, but a lesser amount, e.g., 330°. In thisparticular embodiment, actuator 652 may “top-out” prior to the complete360° rotation of drive wheel 666, thus resulting in e.g., cartridgeassembly 500 being partially pushed out of slot 504 (thus facilitatingeasy removal from automated insertion assembly 10).

A number of implementations have been described. Nevertheless, it willbe understood that various modifications may be made. Accordingly, otherimplementations are within the scope of the following claims.

1. An automated insertion system comprising: a cartridge assemblycomprising: a toothed track; a toothless track; and at least one dermalperforation assembly having an interior passage configured to releasablyengage at least a portion of a subdermal device therein; and anactuation assembly configured to drive the at least one dermalperforation assembly a predetermined distance, the actuation assemblycomprising: a drive gear set comprising an uppermost gear, the drivegear set for engaging the cartridge assembly; an actuator; and a torsionspring, wherein when an uppermost gear of the drive gear set is engagedwith the toothed track of the cartridge assembly, the actuator is raisedand the torsion spring is wound, wherein after the at least one dermalperforation assembly is driven the predetermined distance, an uppermostgear of the drive gear set is seated in the toothless groove.
 2. Theautomated insertion system of claim 1 wherein the subdermal device ischosen from the group consisting of a cannula assembly and a probe. 3.The automated insertion system of claim 1 wherein the at least onedermal perforation assembly comprising: a first insertion needleassembly for at least partially encapsulating at least a portion of thesubdermal device.
 4. The automated insertion system of claim 1 whereinthe actuation assembly comprising: an actuator for providing mechanicalenergy sufficient to drive the at least one dermal perforation apredetermined distance.
 5. The automated insertion system of claim 4wherein the actuator is a spring-based actuator.
 6. The automatedinsertion system of claim 4 wherein the actuation assembly comprising:one or more gear assemblies for at least partially coupling the actuatorto the at least one dermal perforation assembly.
 7. The automatedinsertion system of claim 4 wherein the actuation assembly comprising:one or more linkage assemblies for at least partially coupling theactuator to the at least one dermal perforation assembly.
 8. Theautomated insertion system of claim 1 further comprising: at least twodermal perforation assemblies comprising a first dermal performationassembly and a second dermal perforation assembly, the at first andsecond dermal perforation assemblies configured to releasably engage afirst subdermal device and a second subdermal device respectively; and asecond actuation assembly configured to drive the second dermalperforation assembly.
 9. The automated insertion system of claim 8wherein the second subdermal device is chosen from the group consistingof a canular assembly and a probe.
 10. The automated insertion system ofclaim 8 wherein the second dermal perforation assembly comprising: asecond insertion needle assembly for at least partially encapsulating atleast a portion of the second subdermal device.
 11. The automatedinsertion system of claim 8 wherein the second actuation assemblycomprising: a second actuator for providing mechanical energy sufficientto drive the second dermal perforation assembly a predetermineddistance.
 12. The automated insertion system of claim 11 wherein thesecond actuator is a spring-based actuator.
 13. The automated insertionsystem of claim 11 wherein the second actuation assembly comprising: oneor more gear assemblies for at least partially coupling the secondactuator to the second dermal perforation assembly.
 14. The automatedinsertion system of claim 11 wherein the second actuation assemblycomprising: one or more linkage assemblies for at least partiallycoupling the second actuator to the second dermal perforation assembly.15. The automated insertion system of claim 8 wherein the firstactuation assembly and the second actuation assembly are a singleactuation assembly.